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QA Specialist II Job
Eingestellt von Yoh
Gesuchte Skills: Sap, Client
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Knowledge of SAP and Trackwise.
- Knowledge of cGMPs
WHAT YOU'LL BE DOING:
- Perform final review of manufacturing batch records for manufactured cell banks and clinical large molecule drug substance, drug product and final drug product.
- Compile Batch History Records for Product Manager review.
- Scan documents into our GMP document management system.
- Review and Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
- Provide Quality oversight to internal customers in the Manufacturing organization.
- Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
- Make independent decisions around complex issues in alignment with company's policies.
- Identify and implement process improvements, as necessary.
WHAT YOU NEED TO BRING TO THE TABLE:
- Knowledge of cGMPs or equivalent regulations strongly preferred
- Ability to independently evaluate situations and propose potential solutions
- Ability to interpret Quality standards for implementation
- Ability to communicate clearly and professionally both in writing and verbally
- Flexibility in problem solving and work hours to meet business objectives
- Knowledge of SAP and Trackwise applications and project management skills are highly desirable.
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- BS/BA degree in the life sciences plus five to seven (5-7) years experience.
- A minimum of at least five (5) years experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience.
- Thorough knowledge of cGMPs (Drugs and Biologics), and regulations applicable to U.S. and international Regulatory agencies.
RECRUITER:Mary Nguyen
Yoh, a DayMONJOB
TAX TERM: CON_W2 J2WPACNW
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
South San Francisco, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, SAP Entwicklung